Abbott wins CE mark for dual-chamber leadless pacemaker

Abbott(NYSE: ABT)+ announced today that it received CE mark approval for its Aveir dual-chamber (DR) leadless […]

Abbott(NYSE: ABT)+ announced today that it received CE mark approval for its Aveir dual-chamber (DR) leadless pacemaker system.

Aveir DR, the world’s first dual-chamber leadless pacemaker, treats people with abnormal or slow heart rhythms. It enables a beat-to-beat, wireless communication channel between two leadless pacemakers. One paces the right ventricle (Aveir VR) and the other paces the right atrium (Aveir AR). Each device comes in at roughly one-tenth the size of a traditional pacemaker — smaller than a AAA battery.

The system delivers electrical impulses directly to the heart muscle, restoring the normal heart rhythm. Unlike traditional pacemakers, the leadless devices go directly into the heart through a minimally invasive, catheter-based procedure. This eliminates the need for cardiac leads and a pulse generator under the skin.

Using Abbott’s proprietary i2i (implant-to-implant) technology, the system provides synchronized pacing on every heartbeat based on a person’s clinical needs. i2i technology uses high-frequency pulses to relay messages via the naturally conductive characteristics of the body’s blood between the paired, co-implanted devices. This requires less battery current than inductive, radiofrequency or Bluetooth communication.

Abbott announced in July 2023 that it received FDA approval for the dual-chamber pacemaker system. The company completed the first U.S. commercial cases with Aveir DR in November. Dr. Leonard Ganz, chief medical officer for Abbott’s cardiac rhythm management business, spoke to MassDevice about Aveir DR last year.

“Since its inception, pacemaker technology has remained fundamentally unchanged as seamless synchronization of two leadless pacemakers has been a significant challenge,” Ganz said in a news release. “Aveir DR addresses a critical need for people living with slow heart rhythms and enhances people’s quality of life with its revolutionary leadless design.”

Original article (https://www.massdevice.com/abbott-ce-mark-dual-chamber-leadless-pacemaker/)